Assistance Delivery and Muscle Coordination

NCT07011173 | Recruiting Early Phase 1

• 2 other identifiers: STUDY000067841R15HD114052
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The experiment will be conducted with 15 chronic stroke survivors and 15 control subjects. Subjects will perform extension movements of the index finger of their more-impaired (stroke) or nondominant (control) hand under two different assistance types: end-effector assistance and exotendon assistance. For each assistance type, unassisted movements will be performed before and after the assistance. Subjects will be randomly assigned into two groups (A and B), who will receive the assistance in a different order. The finger movements and muscle activation patterns will be recorded during movements.

Conditions

Stroke

Keywords

Stroke; Muscle coordination; Assistance

Outcome Measures

Primary Outcomes (1)

• Muscle activation pattern

  Coordination of different hand muscles

  Periprocedural

Study Arms (2)

End-effector assistance followed by exotendon assistance

EXPERIMENTAL

Device: Exotendon assistance; Device: End-effector assistance

Exotendon assistance followed by end-effector assistance

EXPERIMENTAL

Device: Exotendon assistance; Device: End-effector assistance

Interventions

Exotendon assistance DEVICE

Assistive devices with distinct assistance dynamics

End-effector assistance followed by exotendon assistance; Exotendon assistance followed by end-effector assistance

End-effector assistance DEVICE

Finger will be moved by the actuators connected to the fingertip

End-effector assistance followed by exotendon assistance; Exotendon assistance followed by end-effector assistance

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 70 years old
• First-ever unilateral cortical stroke with resultant hemiparesis at least 6 months prior to the experimental testing
• Fugl-Meyer Upper Extremity Section 31 - 55

You may not qualify if:

• Presence of concurrent severe medical illness
• Pain in hand or arm with movements
• Loss of voluntary control of fingers and thumb
• Inability to provide informed consent
• Musculoskeletal injuries (e.g., fracture) or medical complications (e.g., severe cardiovascular disease).

Sponsors & Collaborators

• The Catholic University of America: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Catholic University of America

Washington D.C., District of Columbia, 20064, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Helping Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Central Study Contacts

Sang Wook Lee, PhD

CONTACT

202-319-6218; leesw@cua.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 8, 2025
• Study Start: November 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (1)